FDA Recalls Cyclosporin Ophthalmic Vials Due to Sterility Concerns
Axium Healthcare Pharmacy is recalling Cyclosporin (Grapeseed Oil) Ophthalmic vials due to a lack of assurance of sterility and quality control concerns.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance in ophthalmic products, which poses a significant risk of serious injury or infection.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Cyclosporin (Grapeseed Oil) Ophthalmic vials manufactured by Axium Healthcare Pharmacy dba Balanced Solutions Compounding. The recall involves 12 vials (15 mL each) distributed to Colorado, Georgia, Michigan, and Puerto Rico.
The recall was initiated because the compounding pharmacy could not ensure the sterility of the products. The FDA cited concerns associated with the pharmacy's quality control processes as the reason for the action.
Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
- Category
- Drug — Ophthalmic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 26 recalled by Axium Healthcare Pharmacy dba Balanced Solutions Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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